News Feature | June 16, 2014

Oncobiologics Secures EU Approval For Humira Biosimilar Trial

Oncobiologics announced that it has secured approval in the EU to start a Phase I clinical trial for its Humira biosimilar molecule ONS-3010.

ONS-3010 is under development for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. The Humira biosimilar is the company’s leading asset and has completed preclinical development and analytical comparability, including feedback from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The Dutch Competent Authority, the Centrale Commissie Mensgebonden Onderzoek (CCMO), has responded with a Letter of No Objection to the company’s application. Likewise, the Independent Ethics Committee of the Foundation "Evaluation of Ethics in Biomedical Research" has given its approval for a Phase 1 trial to be conducted by the Center for Human Disease Research in Leiden, The Netherlands.

The study of ONS-3010 is expected to be finished before the end of the year. “After a very successful development campaign, we are excited to see our first biosimilar molecule enter this Phase 1 study,” said Oncobiologics Founder & CEO, Pankaj Mohan. Mohan said the trial represents the proof-of-concept for its biosimilars business model, BioSymphony.

Aldeyra CEO Todd Brady, said, “Oncobiologics has been able to satisfy the challenging regulatory hurdles surrounding the development of complex mAb biosimilars. I look forward to the successful completion of this trial as well as the continued advancement of other potential products in the Oncobiologics pipeline.”

Earlier this June Oncobiologics announced a strategic biosimilars partnership with Ipca Laboratories. The two-part alliance was formed for the development, production and marketing of biosimilar monoclonal antibody products to U.S. FDA and EU regulatory standards. Ipca and Oncobiologics plan to launch the first product resulting from the partnership by 2017.

The company announced it is developing other additional biosimilars including versions of Avastin, Herceptin, Rituxan, and Erbitux. Oncobiologics said it plans to kickstart studies for the biosimilar candidates in 2015 and in the following years.